Cerumen impaction remains a significant medical problem. Over 14 million visits are made to physicians every year, many for complaints associated with ear wax impaction. Cerumen impaction can cause hearing loss, tinnitus, pain, infection, and can seriously impair the functioning of hearing aids and tympanostomy tubes. Cerumen impaction is particularly prevalent in the elderly population. This group is more likely to produce hard, dry wax that adheres to the ear canal wall. They are also the group most likely to use hearing aids that impede the natural progression of wax from the ear canal.
There are a variety of techniques available to remove impacted ear wax from the ear canal. Both curettage and irrigation are well known and frequently used procedures that effectively remove ear wax. Another procedure widely used for cerumen removal is suction. This method is particularly effective when the ear wax has a soft, cheese-like consistency. Ear suction is also effective when the ear wax has been treated with a ceruminolytic agent to soften and loosen it, leaving a gooey mess in the ear canal that must be removed to obtain an adequate examination of the tympanic membrane. Suction is also a desirable technique in cases of active infection or with patent tympanostomy tubes, where pus and debris in the ear canal blocks adequate visualization of the ear drum and where irrigation is contraindicated and curettage may be ineffective.
Another cause for ear canal impaction is obstruction with a foreign object. Removal of foreign bodies, as they are called, are well known causes of emergency room and doctor's office visits. It is a particular problem in the pediatric age group, but is not limited to children. The types of foreign bodies found in ear canals range from beads and small toys, to cotton swab tips (from attempts at self-cleaning) and insects. Many of these objects are removed by grasping them with forceps, but round, smooth objects (e.g. beads, stones, toys) are best removed by ear suction.
Currently, ear suction is performed using a re-usable metal suction catheter. The suction catheter comprises a tube with an adaptor for mating with suction tubing, and a small regulating hole or slit that can be covered or uncovered by the user's thumb to break the vacuum as needed. The design of this suction catheter is similar to that of other suction catheters used for a variety of medical purposes. The only difference is that suction catheters used for the ear have a significantly smaller bore size, usually a 7 French or smaller, to accommodate the small diameter of the ear canal. Suction is provided by connection with a standard suction pump or central suction system (as found in hospitals).
One problem with the current ear suction techniques is that it is a “blind” procedure, in that it is difficult for the operator to visualize accurately the suction tip in the ear canal during the suctioning. ENT physicians typically use an operating microscope, or magnifying eye loupes and head-lamp to allow the procedure to be visualized. The current ear suction devices do not have either intrinsic illumination or visualization.